固定剂量复合制剂治疗初治活动性肺结核的效果  

Effectiveness of Initial Treating Active Pulmonary Tuberculosis with Fixed-dosage Combination

作　　者：杨天池[1] 于梅[1] 赵敏捷[1] 顾永权 殷立平[3] 杜飞行[4] 

机构地区：[1]浙江省宁波市疾病预防控制中心,315010 [2]浙江省余姚市疾病预防控制中心,315400 [3]浙江省象山县疾病预防控制中心,315700 [4]浙江省奉化市疾病预防控制中心,315500

出　　处：《中国公共卫生管理》2010年第5期505-507,共3页Chinese Journal of Public Health Management

摘　　要：目的监测固定剂量复合制剂(FDC)在治疗初治活动性肺结核病人中的应用效果,为推广使用提供依据。方法应用FDC制剂治疗3个试点县(市)2008年4月1日～9月30日期间发现的符合要求的初治活动性肺结核病人,使用统一的调查表进行治疗效果和不良反应等的观察和记录。结果监测入选病例235例,其中初治涂阳128例(54.5%),初治涂阴107例(45.5%)。涂阳病例2个月末涂片阴转率为89.3%,治愈率为85.2%,初治失败率为2.5%(3/118);涂阴病例完成疗程率为81.7%,疗程中均未发生痰菌阳转。不良反应的总体发生率为19.1%,以肝功能损害、胃肠道反应和神经系统症状为主。因不良反应而需散装药替代率为46.7%。不良反应发生时间主要集中在开始服药后的2个月内(占78.3%)。药物性肝功能损害发生率为14.0%,最早在疗程第21天,最晚在疗程第147天。结论 FDC制剂具有与现用板式组合药相似的药物特性,但全人群适用性更好。Objective To monitor the effectiveness and adverse reactions（ADRs） of initial treating active tuberculosis with fixed-dosage combination（FDC）,to provide the basis for widely usage.Methods FDC was used to treat initial active tuberculosis cases in 3 experimental counties from April 1 to September 30,2009.Effectiveness and ADRs of FDC were recorded by registration forms.Results For 128 new smear positive patients,the negative conversion rate at the end of second month was 89.3%,the cure rate was 85.2% and the failure rate was 2.5%.For 107 new smear negative patients,the course completion rate was 81.7% and no positive conversion was happened.The total ADRs incidence was 19.1%.The main symptoms were gastro-enteric reaction and neurological syndrome.Bulk drugs replacement rate was 46.7%.78.3% ADRs occurred in 60 days.Drug-induced liver malfunction incidence was 14.0%.The earliest occurrence time was the 21st day of the treatment course and the latest was the 147th day.Conclusion The experimental FDC have an analogy with the present blister pack in medicinal property,but FDC is better in widely applicability.

关 键 词：肺结核 药物疗法 固定剂量复合制剂 不良反应 

分 类 号：R52[医药卫生—内科学]